The Montreal model of ketamine-therapy for alcohol use disorder and comorbid treatment-resistant depression: protocol for a feasibility trial
Christina Mcanulty, Philippe Lavoie, Samuel Cyr, Paola Lavín, Laurent Elkrief, Stephane Richard-devantoy, Élie Rizkallah, Paul Lespérance, Nicolas Gamin, Anna Lembke, Didier Jutras-aswad, Kyle T. Greenway, Nicolas Garel
BMJ Open March 1, 2026 Peer reviewed DOI: 10.1136/bmjopen-2026-116969 via OpenAlex
Summary
The study investigates the feasibility and acceptability of combining acceptance and commitment therapy (ACT) with ketamine for individuals with both alcohol use disorder and treatment-resistant depression. Thirty participants will undergo eight ACT sessions and six ketamine infusions. The main focus is on feasibility, while secondary outcomes will assess recruitment, tolerability, safety, data completeness, and changes in depressive symptoms, alcohol use, and quality of life.
Study at a glance
| Design | feasibility trial |
|---|---|
| Sample size | 30 |
| Population | participants diagnosed with both alcohol use disorder and treatment-resistant depression |
| Key finding | The primary outcome is feasibility, assessed through study completion and protocol adherence. |
Abstract
BACKGROUND: Alcohol use disorder and treatment-resistant depression (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and acceptance and commitment therapy (ACT) can be effective for both substance use and mood disorders. This study explores the feasibility and acceptability of combining ACT with ketamine within the framework of the Montreal Model-a structured, integrative psychedelic ketamine therapy developed for severe TRD. METHODS AND ANALYSIS: This study is a single-group, open-label feasibility trial at the Centre hospitalier de l'Université de Montréal (CHUM) Neuromodulation Ketamine Clinic in Montreal, Canada. 30 participants diagnosed with both alcohol use disorder and treatment-resistant depression will receive eight weekly in-person or virtual ACT sessions in addition to six intravenous ketamine infusions. The primary outcome is feasibility, assessed through study completion and protocol adherence. Secondary outcomes include recruitment rate, tolerability, safety, data completeness and healthcare resource use. Exploratory measures will examine changes in depressive symptoms, alcohol use and quality of life using validated tools. A subset of participants will participate in semistructured qualitative interviews to explore their experiences. ETHICS AND DISSEMINATION: This study was approved by the ethics committee of the CHUM on 14 May 2025. The results of the trial, including primary and secondary outcomes, will be published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT06620276.